Regulatory Affairs Manager

JOB DESCRIPTION

Jubilant Bhartia Group

Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S Bhartia and Mr. Hari S Bhartia with strong presence in diverse sectors like Pharmaceuticals, Contract Research and Development Services, Proprietary Novel Drugs, Life Science Ingredients, Agri Products, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Jubilant Bhartia Group has four flagships Companies- Jubilant Pharmova Limited, Jubilant Ingrevia Limited, Jubilant FoodWorks Limited and Jubilant Industries Limited. Currently the group has a global workforce of around 40,000+ employees.

About Jubilant Ingrevia Limited

Jubilant Ingrevia is now a member of the elite Global Lighthouse Network (GLN) of the World Economic Forum (WEF)

Celebrating our Culture and People.

We are proud to be a Great Place to Work certified!

Jubilant Ingrevia history goes back to 1978 with the incorporation of VAM Organics Limited, which later became Jubilant Organosys and then Jubilant Life Sciences and now demerged to an independent entity as Jubilant Ingrevia Limited, which is listed in both the stock exchanges of India. Over the years, company has developed global capacities and leadership in chosen business segments.

The company is committed to environmental sustainability and supports green chemistry by prioritising the use of bio inputs in manufacturing. Jubilant is one of the world's largest producers of Acetaldehyde from the bio route.

Find out more about us at www.jubilantingrevia.com

The Position:

Organization: - Jubilant Ingrevia Limited

Designation & Level: - Manager – Regulatory Affairs

Location: - Corporate Office – Greater Noida

Reporting Manager: - Vice President & Head- Quality & Regulatory Affairs

Job Summary:

To maintain compliance scheme for both Domestic & International regulations like Cosmetic, Drug master filing and maintenance across the regulatory market – US, Japan, EU, India and emerging region. As the Regulatory Compliance Manager, you will be accountable for leading product regulatory activities in the various region through monitoring, developing and implementing strategies/programs to ensure compliance with the required FSSAI, CDSCO, USFDA , USFFR, EU, Japan and applicable laws per respective country /Geography.

Key Responsibilities:

Regulatory Compliance & monitoring for Nutrition and ingredients:

• New product proposal, budget preparations, data generation and registrations as per the guidelines of food, cosmetic , drug substance category as per respective authority, like, USDDA, USFFR, CDSCO, FSSAI and other relevant authority across the world , in EU, Japan etc.
• Data analysis of various filed products in various geography and evaluate an opportunity to file for the potential products.
• Ensure compliance with existing domestic and international chemical regulations governing cosmetic grade, food items, filter UV-active products, fine chemicals & specialty chemicals.
• Proactively monitor, evaluate business impact and communicate new and amended legislation and regulations.
• Act as a SPOC for DMF & Regulatory filing /amendment in various geography, like in US, EU, WHO, Japan, ROW , CDSCO etc.
• Ensure complete life cycle management of DMF /Dossiers for APIs/active ingredients/intermediates, such as DMF filing, access request, address technical queries of agency & customers, change notification, LOAs, and amendment.
• Managing a data base and RA filing plan across the product value chain in various geography
• Coordinate with internal teams on DMF filing , Food /cosmetic /UV- Active products requirements and ensure readiness of all data.
• Review of relevant documents and DMF /Cosmetic grades prior to filing and ensure right first time filing approach
• Preparation of application for various categories of endorsements viz packaging, label extensions, name change etc.
• Coordination with various Contract Research Organizations (CRO'S) for data generation in chemistry, Packaging and Toxicity. Checking of protocols and study plans for conducting the studies.
• Preparing draft to defend queries raised by the regulatory bodies against any molecule/ product etc.
• Partner with the different functions including R&D, Sales and Supply Chain to communicate regulatory requirements/ information to support business needs
• Interact with regulatory agencies and/or trade associations within defined area(s) of responsibility/expertise, CIB and others as necessary and travel as per business needs to other sites and agency's office to meet
• Monitor regulatory changes, threats and opportunities to evaluate implications towards new and existing registrations
• Ensure compliance with applicable regulations including conducting internal audits at sites to maintain compliance
• Responsible for maintaining proper records, create and manage electronic files of labels and registration certificates.
• Participate and contribute in meetings at Industry forums & committees, Associations and other Government departments
• Keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exporting to.
• To work closely with the international consultants to ensure timely registration.
• Good knowledge of International guidelines like US, Japan, EU, OECD, EPA, ANVISA, APVMA etc.
• Get the high-quality dossiers prepared, compiled and submit in accordance with the regulatory requirements to obtain new registration in the International market like US, Brazil, EU, Japan, LATAM and Asian countries.
• Addressing customer/regulatory queries within timeline with the help of internal CFTs collaborations

Pre-registration / Registration of Cosmetic/Active/Nutraceutical /UV-Filter/chemicals

• Responsible for preparation & filing of pre-registration and registration dossiers of active, Specialty chemicals, Cosmetics, Active, under REACH, FSSAI, CDSCO, USFFR, USFDA , Japan , EU , UK, Brazil and rest of the world and ensuring on-line compliance in the portal.
• Life cycle management of registration of products , across the business vertical and their end application and customers per the current requirements

Assessment of New Product Regulatory Requirements

• Provide regulatory guidance/consultancy to the business and R&D teams on compliance strategies for new and existing products

Substance Volume Tracking

• Responsible for maintaining and monitoring the export volume of the products through the ERP system to comply with the registered volume in the respective countries

Hazard Communication

• Review of Safety Data Sheets & Labels and extend support to business on-line as per regulatory requirement

Customer Queries & Questionnaires

• Provide regulatory inputs on the customer queries & questionnaires.

The Person:

Educational Qualifications & Experience

• Master's degree in Chemistry, Pharmacy, Pharmacology, Biochemistry, or other life science.
• Ph.D in Chemistry or M. Pharma in Pharmacy with relevant certificates in Regulatory Affairs with minimum of 10-15 years of related experience.

Preferred Skills:-

1. Microsoft office

Design Thinking

Team Leadership

Communication Skills

Problem Solving

What's on Offer:

• Opportunity to work with the only Indian company in Global Lighthouse Network under World Economic Forum in the chemical sector.
• Competitive salary and benefits package.
• Career growth opportunities in a rapidly evolving industry